What's New on the FDA Drugs Site
February 23, 2012
- Affordable Care Act (ACA 6004)
- Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
- Comunicado de la FDA sobre la seguridad de los medicamentos: Reingreso planeado al mercado de CardioGen-82 con nuevo recuadro de advertencia
- Drug Shortages: Current Drug Shortages: Methotrexate Injection (updated)
- Guidance for Industry:
- Table of Pharmacogenomic Biomarkers in Drug Labels (updated)
New and Generic Drug Approvals
February 22, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abilify | aripiprazole | Tablet; Oral | Otsuka | Labeling Revision |
| Abilify | aripiprazole | Solution; Oral | Otsuka | Labeling Revision |
| Abilify | aripiprazole | Injectable; Intramuscular | Otsuka | Labeling Revision |
| Bexxar | tositumomab; iodine i 131 tositumomab | Vial | Smithkline Beecham | Manufacturing Change or Addition |
| Finasteride | finasteride | Tablet; Oral | Teva Pharms | Tentative Approval |
| Patanase | olopatadine hydrochloride | Spray, Metered; Nasal | Alcon Pharms Ltd | Labeling Revision |
| Vexol | rimexolone | Suspension/Drops; Ophthalmic | Alcon | Labeling Revision |
| This email was sent to clotito+biotechdash@gmail.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
No comments:
Post a Comment